Gemcitabine With/Out Erlotinib in Unresectable Locally Advanced/Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas Locally advanced or metastatic disease that is considered unresectable No known CNS metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST and/or ALT less than 2 times ULN (5 times ULN if liver metastases present) Renal: Creatinine less than 1.5 times ULN Cardiovascular: No uncontrolled high blood pressure No unstable angina No congestive heart failure No myocardial infarction within the past year No cardiac ventricular arrhythmias requiring medication Gastrointestinal: No gastrointestinal (GI) tract disease resulting in an inability to take oral medication such as uncontrolled inflammatory GI disease (e.g., Crohn's disease or ulcerative colitis) No post-surgical malabsorption characterized by: Uncontrolled diarrhea that results in weight loss and vitamin deficiency OR Requires IV hyperalimentation Pancreatic enzyme supplementation allowed provided that the above criteria are not met Ophthalmic: No ocular inflammation or infection unless fully treated prior to study No significant ophthalmologic abnormalities, including the following: Severe dry eye syndrome Sjogren's syndrome Keratoconjunctivitis sicca Severe exposure keratopathy Disorders that would increase the risk for epithelium-related complications (e.g., bullous keratopathy, aniridia, severe chemical burns, or neutrophilic keratitis) Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No serious active infection No other serious underlying medical, psychological, or geographical condition that would preclude study participation No prior allergic reaction to compounds with similar chemical or biologic composition to erlotinib No other prior malignancy within the past 5 years except cancer in situ or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy or immunotherapy Chemotherapy: No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine administered concurrently with radiotherapy as a radiosensitizer No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: See Chemotherapy At least 4 weeks since prior radiotherapy and recovered Prior radiotherapy for local disease allowed if evidence of disease progression has occurred No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior major surgery No concurrent ophthalmic surgery Other: No prior epidermal growth factor receptor inhibitors At least 2 weeks since prior investigational drug No other concurrent investigational drugs during and for at least 30 days after study No other concurrent anti-cancer therapy
Sites / Locations
- Arizona Clinical Research Center
- Highlands Oncology Group
- Alta Bates Comprehensive Cancer Center
- Sutter Health West Cancer Research Group
- Loma Linda University Cancer Institute
- USC/Norris Comprehensive Cancer Center and Hospital
- Kenmar Research Institute
- Century City Hospital
- David Geffen School of Medicine
- Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
- Davis, Posteraro, & Wasser, MDs, LLP
- New Britain General Hospital
- Eastern Connecticut Hematology and Oncology Associates
- Hematology Oncology, P.C.
- Florida Cancer Specialists
- Oncology-Hematology Group of South Florida
- Ocala Oncology Center
- Oncology & Hematology Associates of West Broward
- Moffitt Clinic at Tampa General Hospital
- Central Georgia Hematology Oncology, P.C.
- Mountain States Tumor Institute
- Northwest Medical Specialists, P.C.
- Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
- Oncology/Hematology Associates of Central Illinois, P.C.
- Midwest Cancer Research Group, Inc.
- Carle Cancer Center
- Medical Consultants
- University of Iowa Hospitals and Clinics
- University of Kansas Medical Center
- Lucille Parker Markey Cancer Center, University of Kentucky
- Norton Healthcare Pavilion
- Mary Bird Perkins Cancer Center
- Tulane Cancer Center
- Annapolis Medical Specialists
- Sinai Hospital of Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Tuft-New England Medical Center
- St. Elizabeth's Medical Center
- Berkshire Physicians and Surgeons, P.C.
- Baystate Medical Center
- University of Minnesota Cancer Center
- Midwest Oncology Consortium
- New Hampshire Oncology-Hematology PA
- St. Barnabas Medical Center
- Hematology-Oncology Associates
- Cooper Cancer Institute
- Cancer Center at Glens Falls Hospital
- Arena Oncology Associates
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
- Beth Israel Medical Center
- Interlakes Oncology/Hematology PC
- Staten Island University Hospital
- University Hospital - Stony Brook
- Presbyterian Hospital
- Mid Dakota Clinic, P.C.
- University Hospitals of Cleveland
- Earle A. Chiles Research Institute at Providence Portland Medical Center
- Hematology-Oncology Association of NE Pennsylvania
- University of Pennsylvania Cancer Center
- Pennsylvania Oncology Hematology Associates
- Fox Chase Cancer Center
- Charleston Hematology-Oncology, P.A.
- Sarah Cannon-Minnie Pearl Cancer Center
- Arlington Cancer Center
- Southwest Regional Cancer Center
- Texas Cancer Care
- University of Texas - MD Anderson Cancer Center
- Tyler Hematology Oncology, P.A.
- Green Mountain Oncology Group
- Hematology & Oncology Associates of Virginia
- Western Washington Oncology
- Southwest Washington Medical Center
- Oncology of Wisconsin
- Hospital Britanico
- Instituto de Oncologia Angel H. Roffo
- Instituto Alexander Fleming
- Hospital Churruca
- Hospital Italiano
- Hospital Interzonal De Augudos Euita
- Confidence Medical Center
- Concord Repatriation General Hospital
- Liverpool Hospital
- Newcastle Mater Misericordiae Hospital
- Institute of Oncology
- Royal Adelaide Hospital
- Ashford Cancer Centre
- Queen Elizabeth Hospital
- Frankston Hospital
- Austin and Repatriation Medical Centre
- Royal Perth Hospital
- Peter MacCallum Cancer Institute
- Institut Jules Bordet
- Nucleo de Oncologia da Bahia
- Hospital Santa Rita Irtmandade Santa Casa De Porto Alegre
- Hospital Israelita Albert Einstein
- Cross Cancer Institute
- British Columbia Cancer Agency - Centre for the Southern Interior
- Penticton Regional Hospital
- British Columbia Cancer Agency - Fraser Valley Cancer Centre
- British Columbia Cancer Agency
- CancerCare Manitoba
- Saint John Regional Hospital
- Newfoundland Cancer Treatment and Research Foundation
- Queen Elizabeth II Health Science Centre
- Royal Victoria Hospital, Barrie
- Cancer Care Ontario-Hamilton Regional Cancer Centre
- Kingston Regional Cancer Centre
- Cancer Care Ontario-London Regional Cancer Centre
- Credit Valley Hospital
- Southlake Regional Health Centre
- Ottawa Regional Cancer Centre
- Peterborough Oncology Clinic
- Algoma District Medical Group
- Hotel Dieu Health Sciences Hospital - Niagara
- Toronto East General Hospital
- Toronto Sunnybrook Regional Cancer Centre
- Ontario Cancer Institute
- Toronto General Hospital
- Saint Joseph's Health Centre - Toronto
- Maisonneuve-Rosemont Hospital
- Hopital Du Sacre-Coeur de Montreal
- L'Hopital Laval
- Allan Blair Cancer Centre
- Clinica Las Condes
- Pamela Youde Nethersole Eastern Hospital
- Queen Mary Hospital
- Virchow Klinikum Humboldt Universitaet Berlin
- Universitaetsklinik und Strahlenklinik - Essen
- Stadtische Kliniken Frankfurt-Hochst
- Tumor Biology Center at the Albert - Ludwigs University
- Martin Luther Universitaet
- Medizinische Universitaetsklinik und Poliklinik
- Universitatsklinik, Saarland
- University Wurzburg
- University Hospital of Heraklion
- Theagenio Medical Institute
- Hippokration Hospital
- Prince of Wales Hospital
- Haemek Medical Center
- Rambam Medical Center
- Rabin Medical Center - Beilinson Campus
- Rabin Medical Center - Golda-Hasharon Campus
- Kaplan Hospital
- Sheba Medical Center
- Tel-Aviv Sourasky Medical Center
- Policlinico - Cattedra di Ematologia
- Instituto Nac de Cancerologia
- Centro Estatal de Cancerologia
- Auckland Hospital
- Christchurch Hospital
- Great Poland Cancer Center
- Dolnoslaskie Centrum Oncology
- Institute of Oncology - Bucarest
- Institutul Oncologic-Universitatea de Medicina
- St. Spiridon University Hospital
- Clinical County Hospital of Sibiu
- National University Hospital
- Singapore General Hospital
- National Cancer Centre - Singapore
- Queen Elizabeth Hospital
- North Middlesex Hospital
- St. Luke's Cancer Center
- Princess Royal Hospital
- Saint Bartholomew's Hospital
- Guy's and St. Thomas' Hospitals NHS Trust
- Christie Hospital N.H.S. Trust
- Northern Centre for Cancer Treatment
- Royal South Hants Hospital
- New Cross Hospital
- Belfast City Hospital Trust
- Velindre Hospital
- Churchill Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
OSI-774 plus Gemcitabine
Placebo plus gemcitabine